DE69422861D1 - Pharmaceutical composition with controlled release based on one or more pharmaceutically acceptable salts of gamma-hydroxybutyric acid - Google Patents

Pharmaceutical composition with controlled release based on one or more pharmaceutically acceptable salts of gamma-hydroxybutyric acid

Info

Publication number
DE69422861D1
DE69422861D1 DE69422861T DE69422861T DE69422861D1 DE 69422861 D1 DE69422861 D1 DE 69422861D1 DE 69422861 T DE69422861 T DE 69422861T DE 69422861 T DE69422861 T DE 69422861T DE 69422861 D1 DE69422861 D1 DE 69422861D1
Authority
DE
Germany
Prior art keywords
pharmaceutically acceptable
controlled release
gamma
pharmaceutical composition
acceptable salts
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
DE69422861T
Other languages
German (de)
Other versions
DE69422861T2 (en
Inventor
Ubaldo Conte
Manna Aldo La
Giuseppe Tessitore
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Laboratorio Farmaceutico CT SRL
Original Assignee
Laboratorio Farmaceutico CT SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Laboratorio Farmaceutico CT SRL filed Critical Laboratorio Farmaceutico CT SRL
Publication of DE69422861D1 publication Critical patent/DE69422861D1/en
Application granted granted Critical
Publication of DE69422861T2 publication Critical patent/DE69422861T2/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32—Alcohol-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/02—Antidotes

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Epidemiology (AREA)
  • Toxicology (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Controlled release pharmaceutical compositions administrable by oral route, containing as the active principle at least one salt of the gamma hydroxy butyric acid with a pharmaceutically acceptable cation, for the treatment of alcoholism, opium like substances addiction, heroin addiction, food and nicotine addiction, depressive and anxious states, composed by: a) a nucleus in the form of granules and tablets comprising an active principle dispersed in a particular cellulosic matrix; and optionally by: b) a filming protection of the nucleus. e
DE69422861T 1993-07-22 1994-07-20 Pharmaceutical composition with controlled release based on one or more pharmaceutically acceptable salts of gamma-hydroxybutyric acid Expired - Fee Related DE69422861T2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT93MI001631A IT1266565B1 (en) 1993-07-22 1993-07-22 PHARMACEUTICAL COMPOSITIONS WITH CONTROLLED RELEASE ON THE BASIS OF ONE OR MORE PHARMACEUTICALLY ACCEPTABLE SALTS OF THE RANGE-HYDROXY-BUTYRIC ACID.

Publications (2)

Publication Number Publication Date
DE69422861D1 true DE69422861D1 (en) 2000-03-09
DE69422861T2 DE69422861T2 (en) 2000-07-27

Family

ID=11366665

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69422861T Expired - Fee Related DE69422861T2 (en) 1993-07-22 1994-07-20 Pharmaceutical composition with controlled release based on one or more pharmaceutically acceptable salts of gamma-hydroxybutyric acid

Country Status (9)

Country Link
US (1) US5594030A (en)
EP (1) EP0635265B1 (en)
JP (1) JP2930875B2 (en)
AT (1) ATE189384T1 (en)
DE (1) DE69422861T2 (en)
HU (1) HUT75150A (en)
IT (1) IT1266565B1 (en)
PL (1) PL176211B1 (en)
RU (1) RU2140266C1 (en)

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US5990162A (en) * 1997-08-29 1999-11-23 Orphan Medical, Inc. Method for treatment of fibromyalgia and chronic fatigue syndrome
CN1148171C (en) 1998-04-17 2004-05-05 大正制药株式会社 Multiple-unit sustained release tablets
JP4367722B2 (en) * 1998-04-17 2009-11-18 大正製薬株式会社 Multiple unit type sustained release tablets
US6211194B1 (en) 1998-04-30 2001-04-03 Duke University Solution containing nicotine
EP1316309A1 (en) * 1998-12-23 2003-06-04 Orphan Medical Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
CA2355293C (en) 1998-12-23 2005-08-16 Orphan Medical, Inc. Microbiologically sound and stable solutions of gamma-hydroxybutyrate salt for the treatment of narcolepsy
FR2805462B1 (en) * 2000-02-24 2003-08-15 Therabel Res NEW ORAL GALENIC FORM WITH EXTENDED RELEASE OF MOLSIDOMINE
US20040020503A1 (en) * 2001-05-01 2004-02-05 Williams Jonnie R. Smokeless tobacco product
US6668839B2 (en) 2001-05-01 2003-12-30 Jonnie R. Williams Smokeless tobacco product
OA12601A (en) * 2001-05-01 2006-06-09 Jonnie R Williams Smokeless tobacco product.
US20060013875A1 (en) * 2002-05-29 2006-01-19 Impax Laboratories, Inc. Combination immediate release controlled release levodopa/carbidopa dosage forms
WO2004041207A2 (en) * 2002-11-01 2004-05-21 Baylor Research Institute Ghb treatment methods
US8627828B2 (en) 2003-11-07 2014-01-14 U.S. Smokeless Tobacco Company Llc Tobacco compositions
BRPI0415741B1 (en) 2003-11-07 2013-07-23 tobacco compositions and methods of manufacturing a tobacco composition
US8193211B2 (en) 2004-09-30 2012-06-05 Supernus Pharmaceuticals, Inc. Controlled release compositions of gamma-hydroxybutyrate
CN100548309C (en) * 2004-11-24 2009-10-14 东北制药总厂 Stavudine sustained release tablet
US20060252830A1 (en) * 2005-05-06 2006-11-09 Brandon Stephen F Method for the treatment of magnesium and potassium deficiencies
US20060252831A1 (en) * 2005-05-06 2006-11-09 Christopher Offen Method for the treatment of magnesium and potassium deficiencies
IL187159A0 (en) * 2007-07-03 2009-02-11 Gur Megiddo Use of metadoxine in relief of alcohol intoxication
US8778398B2 (en) 2008-11-04 2014-07-15 Jazz Pharmaceuticals, Inc. Immediate release formulations and dosage forms of gamma-hydroxybutyrate
US8771735B2 (en) 2008-11-04 2014-07-08 Jazz Pharmaceuticals, Inc. Immediate release dosage forms of sodium oxybate
FR2938431B1 (en) * 2008-11-14 2013-12-20 Debregeas Et Associes Pharma NOVEL COMPOSITION BASED ON GAMMA-HYDROXYBUTYRIC ACID
FR2949062B1 (en) 2009-08-12 2011-09-02 Debregeas Et Associes Pharma NEW PHARMACEUTICAL FORMULATIONS AGAINST MEASURING MEDICINES
FR2949061B1 (en) 2009-08-12 2013-04-19 Debregeas Et Associes Pharma FLOATING MICROGRANULES
EP2476424B1 (en) 2009-08-31 2013-11-13 Zeria Pharmaceutical Co., Ltd. Orally administrable tablet for intestinal lavage
MX2020011961A (en) 2010-03-24 2022-04-19 Jazz Pharmaceuticals Inc Controlled release dosage forms for high dose, water soluble and hygroscopic drug substances.
CN102946869B (en) * 2010-05-04 2016-08-03 爵士制药有限公司 The quick releasing formulation of gamma-hydroxybutyric acid and dosage form
FR2971422B1 (en) 2011-02-11 2016-05-20 Debregeas Et Associes Pharma GAMMA-HYDROXYBUTYRIC ACID GRANULES
JP5977331B2 (en) * 2011-04-06 2016-08-24 ダウ グローバル テクノロジーズ エルエルシー Method for producing cellulose derivative having high bulk density and good fluidity
US8591922B1 (en) 2012-12-14 2013-11-26 Jazz Pharmacuticals, Inc. Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
EP3782614A1 (en) 2013-10-07 2021-02-24 Impax Laboratories, LLC Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
US10987313B2 (en) 2013-10-07 2021-04-27 Impax Laboratories, Llc Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11000498B2 (en) 2016-07-22 2021-05-11 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (en) 2016-07-22 2017-11-30 Flamel Ireland Ltd FORMULATIONS OF GAMMA-MODIFIED RELEASE HYDROXIBUTIRATE WITH IMPROVED PHARMACOCINETICS
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
MX2021005691A (en) 2018-11-19 2021-07-07 Jazz Pharmaceuticals Ireland Ltd Alcohol-resistant drug formulations.
CN113473980A (en) 2019-03-01 2021-10-01 弗拉梅尔爱尔兰有限公司 Gamma-hydroxybutyrate compositions with improved pharmacokinetics in fed state
EP4077262B1 (en) 2019-12-20 2024-07-24 XWPharma Ltd. Methods of synthesizing 4-valyloxybutyric acid
EP4167971A1 (en) 2020-06-18 2023-04-26 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
EP4167966A1 (en) * 2020-06-18 2023-04-26 XWPharma Ltd. Pharmaceutical granulations of water-soluble active pharmaceutical ingredients
US11896573B2 (en) 2020-07-24 2024-02-13 XWPharma Ltd. Pharmaceutical compositions and pharmacokinetics of a gamma-hydroxybutyric acid derivative
WO2022076466A1 (en) 2020-10-05 2022-04-14 XWPharma Ltd. Modified release compositions of a gamma-hydroxybutyric acid derivative
US11986449B2 (en) 2020-12-22 2024-05-21 Amneal Pharmaceuticals Llc Levodopa dosing regimen
US20240156735A1 (en) * 2021-02-09 2024-05-16 Nanjing Nutrabuilding Bio-Tech Co., Ltd. Beta-hydroxybutyrate Salt Granule and Methods for Producing the Same
WO2022170677A1 (en) * 2021-02-09 2022-08-18 Nanjing Nutrabuilding Bio-Tech Co., Ltd. Beta-hydroxybutyrate salt granule and methods for producing it
WO2022198033A1 (en) 2021-03-19 2022-09-22 XWPharma Ltd. Pharmacokinetics of combined release formulations of a gamma-hydroxybutyric acid derivative
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

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Also Published As

Publication number Publication date
PL176211B1 (en) 1999-05-31
ATE189384T1 (en) 2000-02-15
JP2930875B2 (en) 1999-08-09
ITMI931631A1 (en) 1995-01-22
HU9402077D0 (en) 1994-09-28
ITMI931631A0 (en) 1993-07-22
HUT75150A (en) 1997-04-28
US5594030A (en) 1997-01-14
DE69422861T2 (en) 2000-07-27
RU2140266C1 (en) 1999-10-27
PL304389A1 (en) 1995-01-23
EP0635265A1 (en) 1995-01-25
RU94026104A (en) 1996-11-10
IT1266565B1 (en) 1997-01-09
EP0635265B1 (en) 2000-02-02
JPH0753365A (en) 1995-02-28

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Legal Events

Date Code Title Description
8339 Ceased/non-payment of the annual fee